指导原则解读系列专题(十七) 药学研究资料综述撰写的基本考虑(一)

General consideration on organization of summary in pharmaceutical research

药学研究是药物研发的重要组成部分,是药物进行安全性、有效性研究的基础。药学研究资料综述应体现申报品种整个药学研究工作的总结、分析和自我评价内容,它对于注册申请人以及技术审评人员全面、系统地了解申报品种的药学研究内容具有非常重要的意义。文中根据相关技术指导原则,对药学研究综述资料的撰写内容以及需关注的相关技术问题进行了阐述,供药品注册和药学研究工作参考,以提高注册质量和效率。

Pharmaceutical research is a basis for safety and efficacy studies in development process of pharmaceutical products.The summary of pharmaceutical research data should present an overall profile,including analysis and evaluation of results in each part of chemical development studies.The contents should provide comprehensive understanding of the product and its manufacturing process for applicants and reviewers.Based on the relevant guidelines,this article describes the suggested contents and key consideration for applicants and researcher,which will help to improve quality and efficiency of drug registration.